STATEMENT OF WORK2.docx

STATEMENT OF WORK

DESCRIPTION/SPEC/WORK STATEMENT

Blood Gas/Co-Oximetry Analyzers

C.1 The contractor shall furnish the laboratory analyzers, data management systems, all other equipment, reagents, supplies and consumables necessary to operate the contractor's equipment, training for government personnel and equipment maintenance, emergency repair, parts, and preventive service, necessary to fulfill the testing requirements.

C.2 The contract will be based on a Reagent Rental Program over five years (60 months), two (2) Blood Gas/Co-Oximetry Analyzers with accessories, Operator Training, one-year warranty, and four years of instrument service.

C.2.1 All reagents and consumables necessary to perform testing.

C. 2. 2 The contractor will be responsible for validating the use of the analyzers performing accuracy, precision, comparisons, linearity studies and hemoglobin correlations with Hematology analyzer.

C. 2.3. Additional supplies required for commencing operations and all supplies including reagents, cartridges, paper, quality control, and linearity material along with any other supplies not listed that are necessary to perform all required validation studies shall be provided by the contractor at no cost to the government.

C. 2. 4 Training to all equipment operators will be provided on site at no cost to the government prior to day one of GoLive of analyzers.

C. 2. 5 Delivery and installation of equipment.

C. 2. 6 All calibration solutions for automatic and manual calibration if manual calibration required and linearity material necessary to maintain analyzers and perform required parameters.

C.3 Reagents will be provided bearing the same lot number within the designated shipments. These items will be of the highest quality, sensitive, specific and tested to assure precision and accuracy. The contractor must provide stock that meets proficiency testing standards of the College of American Pathologist (CAP), The Joint Commission, the Clinical and Laboratory Standards Institute (CLSI), and be approved by the Food and Drug Administration (FDA).

C.4 Testing System will have the following characteristics:

C.4.1 Disposable multiuse cartridge reagent with contained self-cleaning sample probe to perform blood gas and co-oximetry, requiring the following parameters: pH, pCO2, pO2, tHb, sO2, O2Hb, COHb, MetHb, Deoxy-Hgb, HCO3, Base excess, TCO2, O2 concentration.

C.4.2 Minimal lot to lot variance.

C.4.3 The system must have a Data management system for storage of patient results, quality control and preventative maintenance data and must meet CLIA 88 requirements. System shall be interfaced to the analyzer and capable of being interfaced to the hospital information system (CHCS) for rapid test data transfer and is also capable of being interfaced with Genesis, the hospital information system to be implemented in the future to replace CHCS.

C.4.4 The contractor is required to provide new state of the art equipment. Discontinued models are not acceptable.

C.4.5 The contractor will provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance of date of first commercial availability.

C.4.6 All system shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees Fahrenheit and at any laboratory relative humidity between 40 and 80%.

C.4.7 The analyzer(s) shall be fully operational on the first day of this contract's performance period. Validations, accuracy, precision, comparisons, linearity studies, and hemoglobin correlations with Hematology analyzer shall be performed and completed by day one of contract.

C.4.8 Billing by the vendor will be based type and quantity of supplies ordered and submitted through Wide Area Work Flow. The vendor will provide a courtesy copy of each monthly payment invoice to the operating facility’s COR (Contracting Officer Representative).

C.4.9 The contract period will be for 5 year (60 months), which consist of 1 primary year and 4 option years.

C.4.10 The analyzers shall have the capability to be portable and the dimensions shall not take up more than 24 x 24 x 24 inches when on a benchtop.

C.4. 11 Analyzers shall have the capability to sustain an annual throughput of 2,430 tests. This includes running patient samples, rerunning patient samples due to possible air and/or clots, CAP proficiency testing, 3 levels of quality control ran 3 times a day every 8 hours as well as hemoglobin correlations and linearity studies done twice a year.

C.4.12 Capability to print all hard copy patient results, calibrations, linearity, and quality control. Adequate amount of paper supply to print every result ran on the analyzers. This includes the annual throughput of 2,430--- running patient samples, rerunning patient samples due to possible air and/or clots, CAP proficiency testing, 3 levels of quality control ran 3 times a day every 8 hours as well as hemoglobin correlations and linearity studies done twice a year.

120 samples for hemoglobin correlations/year.

1,205 for quality control runs/year 48 samples for linearity studies/year 30 samples for CAP proficiency testing/year

C.4.14 Low user maintenance required.

C.4.15 Suitable specimen types of venous, arterial, and capillary whole blood.

C.4.16 Barcode scanning available to scan patient ID’s. Scanning of the hospital’s barcoded patient labels shall automatically input patient demographics to include patient first and last name, date of birth, and SSN.

C.4.17 Hard copy of patient result must contain patient demographics to include patient first and last name, date of birth, and SSN as well as results of all required parameters: pH, pCO2, pO2, tHb, sO2, O2Hb, COHb, MetHb, Deoxy-Hgb, HCO3, Base excess, TCO2, O2 concentration and result flags.

C.4.18 Automatic bubble detection in samples that flag user of air in sample.

C.4.19 Analyzers must have easy clot clearance of samples containing clots and are ready for use within three minutes after flushing of clot.

C.4.20 Analyzers must be ready for use upon changeover to new consumables and/or reagents following quality control run. The wait time for analyzer to come back up and register new consumables and/or reagents loaded shall be no more than 5 minutes.

C.4.21 Closed system. No external gas tanks required.

C.4.22 Turnaround time of no more than 90 seconds from time of sample introduction to result availability.

C.4.23 Internal automated quality control programmed to run every 8 hours. Automatic disabling of parameter when quality control is out.

C.4.24 28 day or more shelf life of cartridge when on board analyzer.

EARLY TERMINATION: The government will have the option to terminate this delivery order, without cost to the government, with a 30 day written notice if the analyzer(s) do not perform optimally with minimal operational problems and downtime regardless of guaranteed service, when there is a need to take advantage of improved technology, or if there are changes in mission (operational) requirements to better serve the patient and care providers.

C.4.25 In the event that the contract is terminated for any reason, the contractor must allow the analyzer(s) to remain in place for a period not to exceed 60 days at no cost to the government for the purpose of meeting regulatory requirements of performing correlation/validation studies.

C.4.26 Reagents/Consumables will be ordered and shipped on an as needed basis.

C.5 Special Handling for Emergency Orders of Supplies. In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of verbal order(s) from the government activity. If either circumstance has occurred, the contractor shall deliver to the government, the necessary consumables in sufficient quantity as required allowing operation of the contractor's equipment for one week (under normal government test load volume).

C. 5. 1 In the event the reagent and/or consumables are defective and quality control will not come in after troubleshooting the contractor shall replace the consumable and/or reagent at no cost to the government.

C.6 Site Preparation:

C.6.1 The contractor as a part of the equipment proposal, for any equipment not already in place, shall furnish site preparation specifications in writing. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate and conform to the manufacturer's specifications.

C.6.2 The government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the contractor.

C.6.3 Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the contractor, which would involve additional expense to the government, shall be made at the expense of the contractor.

C.7 Ownership of Equipment:

C.7.1 Title to equipment shall remain with the contractor. All accessories furnished by the contractor shall accompany the equipment when returned to the contractor.

C.7.2 The contractor, at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

C.8 Preventive Maintenance. The government is responsible for any routine operator maintenance. The contractor shall perform ongoing preventive maintenance necessary to fulfill test requirements at no cost to the government.

C.9 Emergency Repair:

C.9.1 Emergency repairs shall be performed after notification that equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification. Entire agreement to include 24 hours per day, 7 days per week Tech support, and a next day loaner when a hardware failure is identified; covering service parts and labor.

C.9.2 The contractor shall perform emergency repair service within 24 hours of the time of notification of malfunction. In the event both analyzers are down simultaneously the contractor shall be required to perform repair service within 4 hours of notification of malfunction. The contractor shall provide all tools, parts and labor needed to repair the malfunction. All expenses occurred with the repair shall be borne by the contractor.

C.9.3 The contractor shall furnish a malfunction incident report to the Contracting Officer Representative upon completion of any maintenance call. A copy of the maintenance report shall be furnished to the Chemistry Supervisor. The report shall include as a minimum, the following: (1) date and time of notification, (2) data and time of arrival, (3) type and model number(s) of equipment, (4) time spent for repair, (4) description of malfunction and (5) proof of repair.

C. 9.4 Any additional costs associated with equipment or supplies not disclosed in the contract, by the contractor, needed for full operation of this equipment, shall be paid by the manufacturer at no cost to the government.